Evaluating bladder catheterization during planned cesarean sections

Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section: Multicenter Non-inferiority Randomized Controlled Trial

This study is testing if skipping the use of a bladder catheter during planned cesarean sections for women who can urinate on their own helps reduce urinary problems after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 550 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University Hospital, Montpellier (other)
• Locations: 2 sites (Montpellier and 1 other locations)
• Trial ID: NCT06357546 on ClinicalTrials.gov

What this trial studies

This trial investigates whether avoiding routine bladder catheterization during planned cesarean sections, for patients who can urinate spontaneously before the procedure, affects the incidence of postpartum urinary retention. It compares two approaches: one where patients urinate naturally prior to surgery and another where a catheter is placed during the operation. The study aims to determine if the absence of catheterization leads to fewer urinary complications within 24 hours post-surgery. This prospective randomized study will provide insights into the benefits and risks associated with catheter use in cesarean deliveries.

Who should consider this trial

Good fit: Ideal candidates include adult women with planned cesarean sections after 34 weeks of pregnancy under spinal anesthesia.

Not a fit: Patients with urinary tract infections, emergency cesarean sections, or contraindications to spinal anesthesia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce urinary complications and discomfort for patients undergoing cesarean sections.

How similar studies have performed: While the current literature does not provide conclusive answers, this study explores a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Adult patient
* Patient admitted for a planned cesarean section after 34 weeks under spinal anesthesia
* Single or twin pregnancy
* Unscarred or with one or two scars of the uterus

Exclusion Criteria:

* Positive urine test strip showing a presence of nitrites or leukocytes, the day before the surgery suggesting asymptomatic bacteriuria
* Emergency Caesarean
* Scheduled Caesarean section with intervention delayed beyond 3 p.m. for service organization reasons
* Epidural anesthesia
* Contraindication to spinal anesthesia (uncorrected hypovolemia; blood coagulation disorders; sepsis or severe inflammation at the puncture site; neurological deficit; migraine pattern; spinal cord disease; spinal malformation; febrile syndrome)
* ASA (American Society of Anesthesiologists) score ≥ 4
* Placental insertion abnormality (placenta previa and/or accreta)
* Medical indication for monitoring of diuresis
* Oliguria or renal failure
* Indication for use of intrathecal clonidine during scheduled cesarean section
* History of bladder surgery or surgical urological pathology during pregnancy (JJ catheter in place)
* History of complex abdominal surgery
* Impossibility or absence of obtaining free, informed and written consent, after a period of reflection
* Patient not affiliated or beneficiary of a national health insurance system
* Patient under legal protection, under guardianship or under curatorship
* Patient having participated in interventional research on a drug within 3 months before inclusion
* Patient participating in another interventional research
* Patient in exclusion period determined by another study

Where this trial is running

Montpellier and 1 other locations

• Montpellier University Hospital — Montpellier, France (RECRUITING)
• Nîmes University Hospital — Nîmes, France (RECRUITING)

Study contacts

• Study coordinator: Audrey LAMOUROUX, MD

Conditions: Pregnant Women, Cesarean Section, Catheterization Urethral, Postpartum Urinary Retention